Tag Archives: FSMA

FDA Clarifies Sanitary Transportation Rule Waiver for Retail Food Establishments

As previously covered on this blog, on April 6, 2016, FDA published a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA).  Click here for a complete copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule, and click here for our summary of the rule and its … Continue Reading

FDA Delays Preventive Controls Inspections for Large Animal Food Facilities

The second major compliance dates are coming up for the Preventive Controls for Animal Food Rule under FDA’s Food Safety Modernization Act (FSMA). On September 18, 2017, larger animal food facilities must comply with preventive controls requirements mandated by FSMA. These facilities had to meet Current Good Manufacturing Practice (CGMP) requirements by September 2016. As … Continue Reading

FDA Issues Guidances on Exemptions from FSMA Rules

As previously reported on this blog, the U.S. Food and Drug Administration issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions under the FDA Food Safety Modernization Act (FSMA) on September 10, 2015. Prior to issuing the FSMA regulations, FDA established: A Seafood Hazard Analysis and Critical Control Point (HACCP) … Continue Reading

FSMA Funds 2017: More Green for Greens

FDA announces FSMA funds to support states’ continued implementation of the produce safety rule. The Food Safety Modernization Act (FSMA) was designed to update and strengthen FDA’s risk-based approach to the oversight of food safety.  The produce safety rule – which establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits … Continue Reading

FDA Launches Accredited Third-Party Certification Website

As previously covered on this blog, in November 2015, the U.S. Food and Drug Administration (FDA) finalized The Food Safety Modernization Act (FSMA) rule on Accredited Third-Party Certification that established a program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and food produced by such … Continue Reading

FDA Slated to Extend Compliance Dates for Agricultural Water Standards

Agricultural water can be a major conduit of pathogens that can contaminate produce. FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes agricultural water standards.  In particular, the Produce Safety Rule sets microbial quality standards for agricultural water, including irrigation water that comes into contact with produce.  In March 2017, the … Continue Reading

Questions (and Answers) on FSVP

As previously covered on this blog, the general compliance date for the foreign supplier verification program (FSVP), under the Food Safety Modernization Act (FSMA), is May 30, 2017 (for a summary of which importers are covered by the general compliance date, see here). The U.S. Food and Drug Administration recently issued additional guidance for importers on … Continue Reading

FDA Issues New Guidance on FSMA’s FSVP Rule

As previously covered on this blog, the general compliance date for the foreign supplier verification program (FSVP), under the Food Safety Modernization Act (FSMA), is May 30, 2017. The U.S. Food and Drug Administration recently issued updated fact sheets, and new guidance on how to identify the importer under the FSVP Rule. The May 30th … Continue Reading

U.S. FDA Recognizes Australia as Having a Comparable Food Safety System

Today, the U.S. Food and Drug Administration (FDA) announced that the Agency has signed an arrangement with the Australian Department of Agriculture and Water Resources recognizing each other’s food safety systems as comparable to one another. This follows FDA’s decision to recognize New Zealand and Canada as comparable foreign food safety systems in 2012 and 2016, … Continue Reading

FDA Announces Three Waivers to Sanitary Transportation Rule

By way of background, on April 5, 2016, FDA released a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA).  Click here for a complete copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule, and click here for our summary of the rule and its implications for … Continue Reading

FDA May Simplify Produce Safety Rule’s Agricultural Water Standards

By way of background, the Produce Safety Rule under FDA’s Food Safety Modernization Act establishes two sets of criteria for microbial water quality based on the presence of generic coli, which can indicate the presence of fecal contamination. The first does not allow any detectable generic E. coli in agricultural water for certain uses, such as water … Continue Reading

Food & Beverage Alliance Asks FDA to Extend PCHF and FSVP Compliance Dates

An alliance of 17 food and beverage trade groups has asked the Food and Drug Administration (FDA) to extend the compliance dates for supplier verification under the Preventive Controls for Human Food (PCHF) and the Foreign Supplier Verification Program (FSVP) final rules, and to align the compliance dates of the two rules. The PCHF and … Continue Reading

FDA Releases Draft Guidance to Help Sprout Operations Comply with Produce Safety Rule

By way of background, the Produce Safety Rule under FDA’s Food Safety Modernization Act implemented new requirements applicable to sprout operations.  Sprouts present a unique risk because the conditions under which they are typically produced are also ideal for the growth of bacteria that cause foodborne illnesses.  FDA reports that between 1996 and July 2016 … Continue Reading

FDA Finalizes FSMA Third-Party Certification User Fee Program

As previously covered on this blog, in November 2015, the FDA announced a final rule regarding the “Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” which established a voluntary program to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements.  As our … Continue Reading

FDA Issues Guidance for Industry on Model Accreditation Standards for Third-Party Certification Bodies

As previously covered on this blog, in November 2015, the FDA announced the implementing final rule “Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” that establishes a program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and food … Continue Reading

FSMA Update: FDA Issues Final Guidance for Voluntary Qualified Importer Program

The FDA has released final industry guidance to support compliance with its Voluntary Qualified Importer Program. The Food Safety Modernization Act (FSMA) (Pub. L. 111-353) required FDA to establish a voluntary, fee-based program called the Voluntary Qualified Importer Program.  This program aims to facilitate the expedited review and importation of foods from importers who achieve … Continue Reading

FSMA Update: FDA Releases FSMA Preventive Controls Guidance for Small Businesses

FDA has released small entity compliance guidances under the Food Safety Modernization Act (FSMA) to support the implementation of the Preventive Controls for Human Food and Preventive Controls for Animal Food rules for small and very small businesses. As previously covered on this blog, over the past several months, FDA has issued guidance documents to … Continue Reading

FSMA Update: FDA Issues Draft Guidance Regarding Suppliers’ Disclosure of Uncontrolled Hazards in Foods

FDA has released draft guidance for industry regarding suppliers’ disclosure of uncontrolled hazards in foods as required by four rules implementing the Food Safety Modernization Act (FSMA). As previously covered on this blog, over the past several months, FDA has issued guidance documents to support the implementation of various FSMA requirements, see e.g., here and … Continue Reading

FSMA Compliance – What to Expect in the Next Few Months

FDA has released a Q&A document regarding the Agency’s expectations going forward for FSMA compliance now that the first set of major FSMA compliance dates have arrived.  The first major FSMA compliance dates arrived on September 19, 2016 for the preventive controls rules for human and animal food under the FDA Food Safety Modernization Act … Continue Reading

FDA Updates Food Facility Registration Product Categories

FDA has issued guidance updating the food product categories that companies can select when registering as a food facility with the agency. Under Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register with FDA.  … Continue Reading

FDA Begins to Deputize States Under FSMA

FDA awards funding to states to help implement FSMA Late last week, FDA announced it would award $21.8 million to 42 states, with the amount per state based on the estimated number of farms growing produce covered by FSMA in that state.  The goals of the partnership are to provide states with financial assistance to develop … Continue Reading

FDA Issues Additional FSMA Draft Guidance Documents for Animal Foods and the Classification of Activities for Farms and Facilities

FDA has issued two draft guidance documents to assist industry with the implementation of Preventive Controls and Current Good Manufacturing Practices under the Animal Food Rule and another draft guidance to assist businesses in determining whether the activities they perform are within the “farm” definition. The two Draft Guidance documents relating to the Animal Food … Continue Reading

FSMA Final Rule: Food Facility Registration

FDA amends food facility registration requirements. Under Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register with FDA.  The registration requirement has been in effect since 2003.  However, the FDA Food Safety Modernization Act … Continue Reading
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